Data / Medical devices / United States / Baxter Healthcare Corporation

Baxter Healthcare Corporation: FDA-registered device maker in Hayward, CA, United States, 3 PMA approvals

Name: Baxter Healthcare Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baxter Healthcare Corporation is registered with the FDA (registration 2937398) in Hayward, CA, United States. It lists 4 device types. The FDA files 3 PMA approvals under its listings, the newest dated March 1, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Baxter Healthcare Corporation

FDA registration number: 2937398
Address: 21026 Alexander Court, Hayward, CA, United States, 94545
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Manufacturer
First device listed: July 3, 2007
Registered through: 2026
Brand names listed: ARS-530 Air Regulator System, Coseal Surgical Sealant, EasySpray, Floseal, PreveLeak

Devices it lists

Device	Product code	Class	Role	Source
Absorbable Collagen Hemostatic Agent With Thrombin	PMX	3	Manufacturer	accessdata.fda.gov
Agent, Absorbable Hemostatic, Collagen Based	LMF	3	Manufacturer	accessdata.fda.gov
Regulator, Pressure, Gas Cylinder	CAN	1	Manufacturer	accessdata.fda.gov
Sealant, Polymerizing	NBE	3	Manufacturer	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 1, 2013	P100030	ARTERX SURGICAL SEALANT	NBE	18	July 10, 2025	accessdata.fda.gov
December 12, 2003	P030039	COSEAL SURGICAL SEALANT	NBE	28	December 18, 2025	accessdata.fda.gov
December 8, 1999	P990009	FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT	PMX	74	November 13, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 12, 2016	74139	Class II	Terminated	COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.	Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.	accessdata.fda.gov

Compare with other makers

Updated July 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.